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Drivemedical

FDA UDI

Class I (US FDA UDI)

by Drive Devilbiss Healthcare

Identity

Trade Name
DRIVEMEDICAL FDA UDI
Generic Name
Alternating-pressure bed mattress overlay system FDA UDI
Device Name
Pressure PreventionSales Samples Product Description: Shearcare 1500 MattressMini Sampl, 1/EA FDA UDI
Model / Reference
1500SCMINI FDA UDI
Description
Pressure PreventionSales Samples Product Description: Shearcare 1500 MattressMini Sampl, 1/EA FDA UDI

Identifiers

Primary DI / UDI-DI
00822383986999 FDA UDI
FDA Product Code
KIC FDA UDI
GMDN Term
Alternating-pressure bed mattress overlay system FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
890.3175 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Alternating-pressure bed mattress overlay systemAlternating-pressure inflatorAlternating-pressure bed mattress overlay, reusable

Drivemedical by Drive Devilbiss Healthcare — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Alternating-pressure bed mattress overlay, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Drive Devilbiss Healthcare

Sources (1)

  • FDA UDI b089d282-ec65-43c5-a9c6-81c220952716 33 fields · synced Jun 8, 2026